Impaired Peripheral Endothelial Function and In-stent Restenosis

Coronary Artery Disease Clinical Trial

Official title:

Impaired Peripheral Endothelial Function as Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131935
• Other study ID #: 1120
• Status: Completed
• Phase: N/A
• First received: May 1, 2014
• Last updated: May 24, 2014
• Start date: January 2010
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI).

Description:

This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: May 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.

Exclusion Criteria:

• Exclusion criteria were balloon angioplasty only without stent deployment, death during hospitalization, and patients who had comorbidities affected RH-PAT results such as hemodialysis, advanced cancer, after surgery of breast cancer, dementia, collagen disease, and not performing RH-PAT with uncertain reason.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Japan	Kumamoto University	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of in-stent restenosis	Based on the Japanese clinical routine, follow-up (F/U) angiography will be performed at six and nine months after PCI with bare-metal stent (BMS) and drug-eluting stent (DES), respectively. ISR was defined as percent diameter stenosis >50% at F/U angiography assessed by quantitative coronary angiography.	within 1 year	No
Secondary	Endothelial Function	Fingertip reactive hyperemia peripheral arterial tonometry (RH-PAT) is a new device that provides noninvasive, automatic, and quantitative evaluation of endothelial dysfunction with low intra- and inter-observer variability. We assess the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI). RHI will be measured using Endo-PAT2000 (Itamar Medical, Caesarea, Israel) before PCI (initial RHI) and at follow-up angiography (F/U RHI) in consecutive patients who had successful PCI in de novo coronary lesions.	within 1 year	No